UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013506 |
|---|---|
| Receipt number | R000015782 |
| Scientific Title | Analysis of marker assoriated with iron and inflammation in allogeneic cell transplantation: multicenter prospecitve study |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2017/01/04 15:47:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of marker assoriated with iron and inflammation in allogeneic cell transplantation: multicenter prospecitve study
Acronym
II-HCT
Scientific Title
Analysis of marker assoriated with iron and inflammation in allogeneic cell transplantation: multicenter prospecitve study
Scientific Title:Acronym
II-HCT
Region
| Japan |
Condition
Condition
Hematologic disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognostic significance of iron and inflammation markers in allogeneic cell transplantation
Basic objectives2
Others
Basic objectives -Others
To evaluated the clinical significance of iron and inflammation markers in post-transplant period.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival at 2 year according to makers
Key secondary outcomes
(1)disease-free survival, non-relapse mortality, and relapse at 2 year according to makers
(2)corelation between ferritin and other markers
(3)relation between markers and transplant-related complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)age more than 16 year old
(2)First allogeneic cell transplantaion
(3)acute leukemia, myelodysplastic syndrome, aplastic anemia, chronic leukemia, adult T-cell leukemia/lymphoma, malicnant lynphoma, multiple myeloma
(4)informed consent
Key exclusion criteria
(1)history of allogeneic cell transplantation
(2) decised unsuitable by associated doctor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Tachibana |
Organization
Yokohama City University
Division name
Internal medicine and clinical immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
tcbnt@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Tachibana |
Organization
Yokohama City University
Division name
Internal medicine and clinical immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
tcbnt@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate of School of Medicine, Yokohama, Japan
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under registration
Management information
Registered date
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
